Tucson company launching late-stage clinical trial for its cancer-prevention drug

Tucson firm moving toward approval of prevention medication

A Tucson company has moved a step closer to launching its first cancer-prevention drug with a late-stage clinical trial.

Tucson-based Cancer Prevention Pharmaceuticals Inc. announced the launch of a three-year, Phase III colon-cancer-prevention trial in collaboration with the National Cancer Institute and SWOG (formerly the Southwest Oncology Group), an NCI-supported clinical-trials group.

The Phase III clinical trial - typically the final trial phase before regulatory approval - will test the company's preventive drug (known as CPP-1X/sul, or eflornithine/sulindac) in 1,340 colon-cancer survivors - each of whom will receive daily treatment for three years to prevent the recurrence of cancer or high-risk polyps.

In an earlier trial, people who had had adenomas - benign tumors - removed from their colon and then took daily eflornithine and sulindac for three years lowered their risk of developing another tumor to less than a third of the three-year risk for those who did not take the drugs, Cancer Pharmaceuticals said. And they lowered their chances of developing a high-risk adenoma during that time by 90 percent.

The new trial is being conducted under Cancer Pharmaceuticals' investigational new drug application, funded mostly by the NCI, and primarily managed by SWOG. It will take place at more than 200 sites around the nation, including the University of Arizona Cancer Center and the Mayo Clinic.

"This is a huge milestone for all of us," said Jeff Jacob, CEO of Cancer Prevention Pharmaceuticals, noting that the company has been working for three years with the NCI and federal regulators to launch the trial.

The company inherited data from earlier Phase I and II trials, Jacob noted. Eugene W. Gerner, University of Arizona professor emeritus and Arizona Cancer Center member, is a co-founder and chief scientific officer of the company.

"It takes many people 12 years to get to this point, so we feel lucky," Jacob said.

Working closely with the U.S. Food and Drug Administration and the NCI, the Tucson company has paved one of the first regulatory paths for cancer-prevention therapies, he said.

"It's not the first (preventive cancer drug), but it's one of the first," Jacob said, citing one breast-cancer drug, Tamoxifen, that is used for prevention of breast cancer in high-risk patients.

The company is also considering supplementing the new trial with a parallel study in Europe or Asia.

Contact Assistant Business Editor David Wichner at dwichner@ azstarnet.com or 573-4181.